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Prior Briefing on the Report of the Inquiry into Bristol Children's Hospital

The report of the review into child cardiac deaths at Bristol Children’s Hospital is to be published on 30 June. Until that moment, we can only speculate on its conclusions, so we have limited means of making comment on its findings.

We have, however, been following the progress of the Review from its inception and can bring to bear insights from legal claims relating to child cardiac surgery at Bristol spanning the past 15 years. Laurence Vick is the solicitor representing most, if not all, of the parents on whose behalf the inquiry was set up; he was joint lead solicitor for parents affected by the Bristol Royal Infirmary Inquiry, culminating in the Kennedy Report of 2001, and continues to act for families whose children died or suffered harm at cardiac units across the country.

He is, therefore, in a position to provide a detailed briefing on the progress, and the controversies, of the inquiry, as well as drawing attention to the questions we hope it has asked and the answers called for by the families. At the start of the Inquiry process, he offered his assistance to Eleanor Grey QC, chair of the Review panel, but acknowledges that he has not formally represented the families in this Review, which is considering aspects of treatment that go beyond those involved in litigation.

This document is not, of course, intended to criticise the report before its publication; it is an accumulation of issues and concerns that have emerged either before the inquiry was set up or during the two-year course of its investigations. Since we have no means of best-guessing the Review's findings, this is an inquiry into the inquiry – a ‘crib sheet’ addressing those areas of concern for the families that, it is hoped, the report will highlight. We put forward the context of the Review and pose questions that we, and the families, feel must be answered.

Failures of the hospital’s clinical services

Paragraph 4 of the Review's terms of reference states that the inquiry will:

Assess the degree to which progress has been made in implementing those recommendations relevant to this review contained in the Report of the Bristol Royal Infirmary Public Inquiry published in 2001.

The families drew attention to an independent review of congenital and paediatric cardiac services at Bristol, conducted in March 2008 by Dr Michael Godman and Mr Roger Mee. It identified a wide range of problems at the unit, with recommendations as to the steps that needed to be taken to address those shortcomings. The Review is also aware of the concerns raised by Mr Ash Pawade, the surgeon who replaced James Wisheart as the senior paediatric cardiac surgeon at the unit in 1996 but left in 2007.

Obviously, if problems were identified in the Godman-Mee report a full seven years after the Kennedy report, this must suggest that outstanding issues at Bristol had not been resolved: hence the families' belief that the review should have analysed the outcomes of all surgery undertaken at the unit in the intervening years, or at least since the problems revealed in the this 2008 report.

Was this report considered by the inquiry? If it was, why were failings prior to 2010 not included in the terms of reference? If it was not considered, why not? The families, who have fought for years for answers about their children's care, are understandably led to question whether the Trust or NHS England had any influence in this decision.

Some parents seek reassurance that the decision to restrict the terms of reference to the period after 2010 was not a deliberate attempt to exclude this evidence from the inquiry; they query whether this would exclude evidence showing that the problems at the Trust were of much longer standing than had been admitted.

In the update of 22 July 2015 on the inquiry website, reference was made to 239 more families who had been in touch with the review, 'most with concerns' over the treatment their children had received, as the inquiry expressed it. There has been no further explanation for this figure or of how these submissions were subsequently dealt with. However, in the trust's Root Cause Analysis (RCA) into the death of Luke Jenkins on 9 April 2012 (following a failed Fontan operation), two of the Trust's staff, PICU consultant Dr Sara-Louise Hulme and patient safety manager Annette Marshall (members of the cardiac clinical governance group) agreed to review the previous 50 paediatric cardiac deaths in which they would reference the Institute of Improvement Morbidity Review template.

The issue was raised with the Review by Mr Jenkins and they in turn asked for clarification from the Trust, asking what became of this analysis. Pages 28/29 of the RCA also included the Trust's commitment to review all paediatric cardiac deaths in a rapid action meeting as soon as possible following a death. This review would therefore appear to be a source of relevant information that should be made available by the trust. This RCA has been shared among the families and is posted on the Jenkins family's website. We do not know the circumstances or the period over which these deaths occurred, and it is impossible to establish whether the deaths involved shortcomings in care or were entirely unavoidable. Either way, surely this analysis would have provided an invaluable opportunity to learn lessons.

Did the Review follow up this evidence and is it mentioned in the findings? Why, since it was clearly relevant, did the Trust not volunteer the information itself? If in fact the Trust did not complete this review, accepting that we do not know the period of time involved, the acknowledgement that there had been this number of deaths must surely be of note.

This evidence suggests tangible problems at Bristol, and the families were understandably unhappy with what they fear was the Trust taking steps to bring about a narrowing of the inquiry's investigation. Ms Grey has assured us that this has not been the case but the question remains in the minds of the parents: if the Trust failed to disclose this evidence, is there more it ought to have disclosed?

We know, from an update posted by the Review on 18 March, that warning letters were sent to certain individuals in the Trust prior to publication. This process, sometimes known as 'Maxwellisation', allows individuals who are due to be criticised in an inquiry to respond before the findings are released. This suggests that certain individuals will face criticism in the Review, although who these people will be and what form the criticism takes remains unclear.

One fear among the parents of children harmed in operations before 2010 is that the inquiry may risk becoming a re-run of the Bristol scandal of the 1990s, with the GMC and public inquiry failing to properly address the incidence of brain damage and other non-fatal injuries at the unit. Morbidity incidences were not examined, though it should have been crucial to understanding the full implications of the problems at Bristol Royal Infirmary in that era. We came to describe the parents of children who suffered brain damage following surgery at the unit as ‘the forgotten families’ who, years later, were sometimes still fighting through the courts for justice on behalf of their often severely brain damaged children.

Similarly, morbidity data from the unit under scrutiny here is also likely to be crucial. There is evidence suggesting that a high incidence of neurological damage will go hand in hand with high mortality rates and, hopefully, the expert panel will feel it appropriate to obtain all relevant data from the Trust in order to assess overall the safety of the unit. This is, of course, hugely complex surgery with a wide range of attendant risks and it is important for parents of prospective patients to know that a particular unit has the expertise and experience to address, and hopefully minimise, the effects of the complications that can arise.

Has the Trust disclosed evidence to the inquiry on its morbidity record over the relevant period? Has the inquiry’s expert panel felt it appropriate to obtain all relevant data from the trust so to determine the unit’s safety?

'Whistleblowers' and the Duty of Candour

It is clear that there were ongoing concerns among staff at the hospital regarding patient safety. The CQC report dated November 2012 referred to 10 'expressions of concern' by Trust employees in the seven-month period leading up to the inspection in December 2012.

The families' cynicism towards the Trust and its attitudes has been further exacerbated by revelations in the national press of what appears to be a cover-up involving another child, Benjamin Condon, who died at Bristol Children's Hospital in April 2015. Although that case is not being considered by the Review, as it does relate to cardiac surgery, at least one of the consultants who was directly involved in explaining the hospital’s position to the parents also features in the inquiry.

A recording of part of one of the child death review meetings attended by this family late last year revealed what seems to have been a deliberate attempt by the Trust to conceal admissions of potential failings in Ben's care, and further instances of misleading information given to the parents were confirmed in an independent report by Verita (addressing quality of communication, frankness and transparency with families and not clinical care). The Trust apologised unreservedly in response to the report. The question posed by some parents is that, if some members of the Trust can deliberately attempt to cover up the circumstances of one child’s death, can they do it for others?

The Inquest into Ben's death concluded on 22 June 2016, with the Coroner hearing evidence from Trust staff and an independent expert. From the family's perspective, the clinical picture of his treatment and death remains unclear, with several witnesses for the Trust resiling from the findings of earlier internal hospital investigation documents and what had been told to the family. In a statement read to the media, the family said that they 'felt no more reassured after the evidence [they] heard during the Inquest.'

The journey for seven-year-old Luke Jenkins' parents in establishing the truth behind his treatment and death further calls into question the behaviour of the Trust and its staff, suggesting, to them, what appear to be more apparent cover-ups. Nor does this sit well with the Duty of Candour obligations the Trust would face if these events had taken place today, with the duty now in force. The inquiry’s terms of reference state that it is to:

Explore the candour and quality of communication, and the explanation and support made available, to families using the service.

To put this into context, a review of a serious incident panel report, conducted by the Division of Women's and Children's Services at Bristol, was delivered to the Jenkins' house anonymously shortly after the conclusion of the Inquest into Luke's death. It had not been revealed or made available to the Coroner before the Trust's witnesses gave evidence under oath. It can only be supposed that this document, which the Trust evidently did not want the family to see, was leaked by a whistleblower.

The serious incident panel report itself was not disclosed to the family until just before the last pre-inquest review in October 2013.

As a number of the families will have confirmed to the Review, they feel that they were given explanations from the Trust that were misleading. Following a series of Inquests before the Avon Coroner, a damaging series of news stories began to highlight the shortcomings of the hospital, and the Trust, according to the Western Daily Press, spent £25,300 to hire the public relations company Grayling to 'manage enquiries around its heart unit'. The Trust confirmed that Grayling had been hired on a month by month basis to provide 'additional support communications about paediatric cardiac services given the significant increase in media attention and stakeholder interest in the service'. Hiring a PR agency at that time may have been an entirely legitimate step to be taken by the Trust but, the families saw this as an attempt by the hospital to ‘take them on’ and offer misleading 'spin'.

Did the inquiry follow up the 10 expressions of concern identified by the CQC?

Did the inquiry obtain evidence from the individuals who communicated these concerns to the CQC? If not, given that the inquiry has apparently been told of the 'leaks' by parents, why did the inquiry not demand this evidence from the Trust?

Role of NHS England & its internal politics

The joy felt by families at the initiative by Professor Sir Bruce Keogh to set up an independent inquiry in 2014 was quickly dissipated, however. Professor Keogh promised that this would be ‘the families’ inquiry’ and that they would be central to it.

Subsequently, and throughout, the families have complained of feeling shut out of the inquiry proceedings. What was supposed to have offered them some control, and was supposedly to have been ‘the families’ inquiry’, has instead – and I stress, this is in their eyes – shut its doors to them. In the way it was set up, it seems not to have prioritised the kind of transparent examination they feel they had been promised.

This issue is exemplified by the question of the terms of reference. In spite of there being evidence of problems at the unit stretching back several years, the terms of reference set the timeframe for the inquiry as beginning in 2010. The families felt they were being ‘bounced’ into accepting a fait accompli.

This decision effectively to limit scrutiny of problems at the unit only after 2010 was, we understand, taken by NHS England, who had set up the inquiry. No substantive reason has been given by NHS England for the decision. The parents feared that NHS England was leaning towards limiting scope of the inquiry to protect the Trust, at a time when there had still been no final decision on the network of child cardiac services nationally.

To the further disappointment of the families, although the terms of reference ruled out scrutinizing operations before 2010, the inquiry has nevertheless taken submissions from (and met with) families whose children apparently underwent successful surgery at the unit in the years before this cut-off date – meetings that they fear have been presented to the press as 'good news stories' by the Trust or its PR agency. As the angry families point out, asking children between 5 and 18 years old what their experiences had been at the unit, some years before, would mean that at the time they were asked to recall, they would have been babies.

What was the purpose of inviting in these ‘content’ families? will the inquiry explain this? Was it always the intention of the inquiry to bring them in and at whose suggestion was it? The Trust? NHS England?

Wider implications for child cardiac surgery

It has been something of a puzzle that this inquiry has been running in parallel with the national Safe and Sustainable programme which, following the intervention of Jeremy Hunt as Secretary of State for Health, was rebranded as the New Review of paediatric cardiac units. Both programmes have proved highly contentious. Safe and Sustainable was rejected by several hospital trusts which felt that their child cardiac units would be under threat, since it imposed a rigid requirement for units to employ four full-time specialist paediatric cardiac surgeons carrying out a total of 400 operations annually. Our understanding is that Bristol is to join a network with Birmingham and Leicester, so as to make up these mandated numbers and sharing expertise. However, this remains at the discussion stage.

With this controversy still unresolved, the Bristol Review has faced the potentially invidious position of assessing the performance and safety of Bristol's chid cardiac unit before NHS England makes its final decision on the national network?

Does the inquiry report address the national child cardiac picture, or explain how its findings relate to the national picture?

Criticism of the inquiry itself

The inquiry has been the subject of concern and criticism from parents and their supporters, who feared that it was being unduly influenced by NHS England and the Trust. We are not in a position to support or question those concerns. However, they might have been alleviated, or even avoided, had the Review perhaps done more to accommodate the questions and concerns of the discontented of parents. We accept entirely that the inquiry has had to ensure that it follows a fair process and has necessarily isolated itself to some extent in order to perform its function. Indeed, the Trust would have legitimate complaint if they suspected that the families had been given excessive opportunity to influence the Review. Unfortunately, that isolation appears to have been interpreted, by some families, as a lack of transparency.

We recognise that the Review will not have had unlimited funds available to it and that the task of carrying out such a detailed investigation, with an extensive panel of experts, will have been daunting. Nevertheless, these are parents of children who died or suffered harm under the care of the Trust and, whether or not these result from failings at the unit, the anguish that they have gone through over the past two years cannot be underestimated.

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